Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients (NNNB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age ≥ 18 years old at the run-in visit

HIV-1 infection

Antiretroviral treatment-naive

CD4 ≥ 200 /mm3

HIV- RNA ≥ 1000 copies/ml

HIV-RNA ≤ 100,000 copies/ml

Antiretroviral therapy is indicated according to current guidelines

CCR5-tropic virus according to the Trofile ES® assayGeno2Pheno algorithm using a predefined false positive rate of 20%

No significant NRTI, NNRTI or PI resistance mutation

Freely-given, written, informed consent obtained; the patient and investigator have signed the consent form (by the latest on the day of the run-in visit and before performing any examinations required by the trial)

Patient covered by a French national health insurance scheme

Exclusion Criteria:

Women of child-bearing potential not using effective contraception (barrier method)

Pregnant or breast-feeding women

Patients under the age of 18 years

Patients deprived of liberty by a judicial or administrative, hospitalized patients without consent, patients admitted to a health or social purposes other than research

Persons major subject of a measure of legal protection or unable to consent

Previous antiretroviral therapy (with the exception of post-exposure prophylaxis if HIV serology is negative > 3 months after the last dose of antiretroviral drugs)

HIV-HBV co-infection. Patients with HIV-HCV co-infection are permitted to participate in the absence of decompensated cirrhosis (Child-Pugh class B or C), of hepatocytolysis > 3 times the upper limit of normal and if treatment for HCV during the ensuing 12 months is not indicated. PAtients with occult HBV are excluded.( positive AcHBc, negative AcHBs, negative AgHBs, positive HBV DNA)